Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients.
Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients.
复制标题
DOI：
10.1186/1477-7525-3-55
复制
发表时间：
2005-09-07
影响因子：
3.6
通讯作者：
O'Boyle, Ciaran A
中科院分区：
文献类型：
--
作者：
Ring, Lena;Hofer, Stefan;O'Boyle, Ciaran A
背景：生活质量(QOL)现在被确定为评估疾病影响和治疗效果的重要结果。然而，个体会随着时间的推移而变化，他们做出QOL判断的基础也可能会改变，这种现象越来越多地被称为反应转移。在这里，个体可能由于外部因素，例如治疗或健康状况的改变，而改变他或她在目标结构上的内部标准、价值观和/或概念化。这对评估治疗的效果具有重要意义，因为生活质量的变化可能反映出反应的转变、治疗效果或两者的复杂组合。在这项研究中，我们使用了个性化的生活质量(IQOL)测量，SEIQOL，以及随后的测试，以确定反应变化是否会影响对无牙颌患者治疗效果的测量。方法：这里报告了一项随机对照临床试验的第一阶段的数据，该试验旨在评估种植支持义齿与高质量传统义齿对IQL的影响。使用SEIQOL-DW对117名患者(平均年龄64.8岁，男性占32%)在基线(T1)和接受高质量传统义齿后3个月(T2)进行了IQOL测量。这项研究是在都柏林和贝尔法斯特的牙科教学医院进行的。结果：未经调整的SEIQOL指数评分显示，治疗3个月时没有显著影响(基线：75.0；3个月：73.2，p=.33，N.S.)。然而，3个月后的测试显示，患者对基线生活质量的回顾评分明显低于当时的评分(P<；.001)(当时的测试基线：69.2)。3个月的评分与调整后的基线相比较，显示出显著的治疗效果(当时的测试基线：69.2.3个月：73.2p=0.016)。81%的患者在3个月时至少提名了一个不同的IQOL领域。结论：只有在考虑反应转移的情况下，义齿治疗才能对IQL产生积极影响。反应转变的性质非常复杂，但数据表明重新概念化和重新确定优先次序的程度。使用患者生成的报告评估治疗的影响必须考虑到患者的适应性。
BACKGROUND: Quality of life (QoL) is now established as an important outcome for evaluating the impact of disease, and for assessing the efficacy of treatments. However, individuals change with time and the basis on which they make a QoL judgement may also change, a phenomenon increasingly referred to as response shift. Here, the individual may change his or her internal standards, values, and/or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status. This has important implications for assessing the effects of treatments as a change in QoL may reflect a response shift, a treatment effect, or a complex combination of both. In this study, we used an individualised quality of life (IQoL) measure, the SEIQoL, together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients.METHODS: Data are reported here for the first phase of a randomised controlled clinical trial designed to assess the impact, on IQoL, of implant supported dentures compared with high quality conventional dentures. IQoL was measured using the SEIQoL-DW in 117 patients (mean age 64.8; 32% male) at baseline (T1) and 3 months (T2) after receiving high quality conventional dentures. The work was carried out in dental teaching hospitals in Dublin and Belfast.RESULTS: Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months (baseline: 75.0; 3 months: 73.2, p = .33, n.s.). However, the then-test at 3 months revealed that patients retrospectively rated their baseline IQoL as significantly lower (P < .001) than they had rated it at the time (then-test baseline: 69.2). Comparison of the 3 month scores with this readjusted baseline indicated a significant treatment effect (then-test baseline: 69.2; 3 months: 73.2, p = 0.016). 81% of patients nominated at least one different IQoL domain at 3 months.CONCLUSION: The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration. The nature of the response shifts was highly complex but the data indicated a degree of re-conceptualization and reprioritisation. Assessment of the impact of treatments using patient-generated reports must take account of the adaptive nature of patients.